Breathing assistance apparatus with a manifold to add auxiliary gases to ambient gases

ABSTRACT

The breathing assistance apparatus of the present invention includes a manifold that is provided with or retrofittable to gases supply and humidifying devices. The manifold allows gases from an oxygen concentrator to be combined with the flow through a gases supply and humidifying device, most usually air. The combined output of oxygen and other breathing gases (air) is then humidified. The breathing assistance apparatus and manifold of the present invention provides a safe method to add oxygen to the input air stream of a gases supply and humidifying device and reduces the amount of accumulation of oxygen within the gases supply device, reducing fire risk should sparking occur within the device.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

This application is a continuation of U.S. application Ser. No.17/645,938, filed Dec. 23, 2021, which is a continuation of U.S.application Ser. No. 16/905,244, filed Jun. 18, 2020, which is acontinuation of U.S. application Ser. No. 15/601,395, filed May 22,2017, Issued as U.S. Pat. No. 10,722,675, which is a continuation ofU.S. application Ser. No. 14/286,590, filed May 23, 2014, Issued as U.S.Pat. No. 9,656,039, which is a continuation of U.S. application Ser. No.11/916,503, filed Feb. 11, 2008, Issued as U.S. Pat. No. 8,733,353,which is a National Phase filing of PCT/NZ2006/000166, having anInternational filing date of Jun. 29, 2006, which claims priority to NewZealand Application No. 541083 filed on Jul. 1, 2005. The entirecontents of each of the aforementioned patents/applications is herebyincorporated by reference, for all purposes.

BACKGROUND Field

This invention relates to a gases supply and gases humidificationapparatus including a manifold that allows for the addition of oxygen tothe gases supply.

Related Art

A number of methods are known in the art for assisting a patient'sbreathing. Continuous Positive Airway Pressure (CPAP) involves theadministration of air under pressure to a patient, usually by a nasalmask. It is used in the treatment of snoring and Obstructive SleepApnoea (OSA), a condition characterized by repetitive collapse of theupper airway during inspiration. Positive pressure splints the upperairway open, preventing its collapse. Treatment of OSA with nasal CPAPhas proven to be both effective and safe, but CPAP is difficult to useand the majority of patients experience significant side effects,particularly in the early stages of treatment.

Upper airway symptoms adversely affect treatment with CPAP. Mucosaldrying is uncomfortable and may awaken patients during the night.Rebound nasal congestion commonly occurs during the following day,simulating a viral infection. If untreated, upper airway symptomsadversely affect rates of CPAP use.

Increases in nasal resistance may affect the level of CPAP treatmentdelivered to the pharynx, and reduce the effectiveness of treatment. Anindividual pressure is determined for each patient using CPAP and thispressure is set at the patient interface. Changes in nasal resistanceaffect pressure delivered to the pharynx and if the changes are ofsufficient magnitude there may be recurrence of snoring or airwaycollapse or reduce the level of pressure applied to the lungs.

CPAP is also commonly used for treatment of patients with a variety ofrespiratory illnesses or diseases, including Chronic ObstructivePulmonary Disease (COPD).

Oxygen is the most common drug prescribed to hospitalized patients withrespiratory or other illnesses. The delivery of oxygen via nasal cannulaor facemask is of benefit to a patient complaining of breathlessness. Byincreasing the fraction of inspired oxygen, oxygen therapy reduces theeffort to breathe and can correct resulting hypoxia (a low level ofoxygen in the tissues).

The duration of the therapy depends on the underlying illness. Forexample, postoperative patients may only receive oxygen while recoveringfrom surgery while patients with COPD require oxygen 16 to 18 hours perday.

Currently greater than 16 million adults are afflicted with COPD, anumbrella term that describes a group of lung diseases characterized byirreversible airflow limitation that is associated mainly with emphysemaand chronic bronchitis, most commonly caused by smoking over severaldecades. When airway limitation is moderately advanced, it manifests asperpetual breathlessness without physical exertion. Situations such as atracheobronchial infection, heart failure and also environmentalexposure can incite an exacerbation of COPD that requireshospitalization until the acute breathlessness is under control. Duringan acute exacerbation of COPD, the patient usually experiences anincrease in difficulty of breathing (dyspnea), hypoxia, and increase insputum volume and purulence and increased coughing.

Oxygen therapy provides enormous benefit to patients with an acuteexacerbation of COPD who are hypoxic, by decreasing the risk of vitalorgan failure and reducing dyspnea. The major complication associatedwith oxygen therapy is hypercarpnia (an elevation in blood carbondioxide levels) and subsequent respiratory failure. Therefore, the doseof oxygen administered is important.

To accurately control an oxygen dose given to a patient, theoxygen-enriched gas must exceed the patient's peak inspiratory flow toprevent the entrainment of room air and dilution of the oxygen. Toachieve this, flows of greater than 20 L/min are common. Such flows ofdry gases cause dehydration and inflammation of the nasal passages andairways if delivered by nasal cannula. To avoid this occurrence, aheated humidifier may be used.

The majority of systems that are used for oxygen therapy or merelydelivery of gases to a patient consists of a gases supply, a humidifierand conduit. Interfaces include facemasks, oral mouthpieces,tracheostomy inlets and nasal cannula, the latter then having theadvantage of being more comfortable and acceptable to the patient than afacemask.

It is usual for the gases supply to provide a constant, prescribed levelof gases flow to the humidifier. The humidifier and conduit can thenheat and humidify the gases to a set temperature and humidity beforedelivery to the patient. Many patients using blowers or continuouspositive pressure devices to treat COPD are on long term oxygen therapy.Such patients often need in excess of 15 hours per day of oxygen therapyand as such the only practical method to expose these patients toseveral hours humidification therapy per day as well as oxygen therapyis to combine the oxygen therapy and humidification therapy. As theoxygen therapy is known to dry the airways there are likely to bebenefits from combining the treatments.

Currently CPAP systems are commonly integrated with oxygen flow systemsto provide increased fraction of oxygen for the treatment of respiratorydisorders. These systems commonly combine the oxygen source on the highpressure (flow outlet) side of the blower. This results in three maindisadvantages. Firstly, by integrating the oxygen on the high pressureside, a connection port with a sealing cap is required to seal off theoxygen inlet port and avoid high pressure gases escaping when the oxygenflow source is not connected. Secondly, in the event that the oxygensource is turned on before the blower is turned on the breathingcircuit, humidification chamber and blower become flooded with 100%oxygen. This is likely to create a fire safety risk if sparking shouldoccur within the blower or heated breathing tube when turned on.Thirdly, if the oxygen gases source is added at the outlet of thehumidification chamber, the oxygen gas, when mixed with other gasesdelivered to the patient, lowers the overall humidity of the gasesdelivered.

SUMMARY

It is an object of the present invention to provide a breathingassistance apparatus that goes some way to overcoming the abovementioneddisadvantages or that at least provides the public or industry with auseful choice.

Accordingly in a first aspect the present invention consists in abreathing assistance apparatus adapted to deliver humidified gases to apatient comprising:

a gases supply having an inlet in which gases are drawn through,humidification means including a humidification chamber having anoutlet, said gases flowing from said inlet through said humidificationchamber and out said outlet, and manifold on or about said gases supplyinlet that enables oxygen or other gases to be added to said gases.

Preferably said manifold includes an oxygen inlet port capable of beingconnected to an oxygen supply.

Preferably said manifold is substantially rectangular.

Preferably said manifold includes at least one aperture to allow thedrawing of other gases into said manifold.

Preferably said gases supply includes an internal sensor that is capableof sensing the fraction of oxygen flowing through said breathingassistance apparatus.

Preferably said gases supply includes a controller connected to saidinternal sensor.

Preferably said gases supply includes a display controlled by saidcontroller and said controller causes said fraction of oxygen to bedisplayed and updated on said display.

To those skilled in the art to which the invention relates, many changesin construction and widely differing embodiments and applications of theinvention will suggest themselves without departing from the scope ofthe invention as defined in the appended claims. The disclosures and thedescriptions herein are purely illustrative and are not intended to bein any sense limiting.

In this specification where reference has been made to patentspecifications, other external documents, or other sources ofinformation, this is generally for the purpose of providing a contextfor discussing the features of the invention. Unless specifically statedotherwise, reference to such external documents is not to be construedas an admission that such documents, or such sources of information, inany jurisdiction, are prior art, or form part of the common generalknowledge in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

One preferred form of the present invention will now be described withreference to the accompanying drawings.

FIGS. 1A-1B are illustrations of the breathing assistance apparatus thatmay utilize the manifold of the present invention.

FIG. 2 is a rear view of a blower and humidifier apparatus with amanifold of the present invention installed.

FIG. 3 is a rear view of the manifold of the present invention.

FIG. 4 is a first perspective view of the manifold of FIG. 3.

FIG. 5 is a second perspective view of the manifold of FIG. 3.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The breathing assistance apparatus of the present invention includes amanifold that is preferably provided with or retrofittable to gasessupply and humidifying devices. The manifold allows gases from an oxygenconcentrator to be combined with the flow through a gases supply andhumidifying device, most usually air. The combined output of oxygen andother breathing gases (air) is then humidified.

The breathing assistance apparatus and manifold of the present inventionprovides a safe method to add oxygen to the input air stream of a gasessupply and humidifying device and reduces the amount of accumulation ofoxygen within the gases supply device, reducing fire risk shouldsparking occur within the device.

The present invention provides a breathing assistance apparatus wherethe flow of gases passes in sequence through a gases supply means orflow driver (such as, a blower, fan or compressor), humidificationchamber, heated delivery circuit, then to a patient interface, such asthat shown in FIGS. 1A-1B.

Gases are passed to the patient 1 by way of a patient interface 2. Thepatient interface used with the apparatus of the present invention maybe a full-face mask, nasal mask, nasal cannula, oral mouthpiece ortracheostomy connection, but the description below and figures disclosethe use of a nasal cannula.

With reference to FIGS. 1A-1B the humidification apparatus of thepresent invention is shown in which a patient 1 is receiving humidifiedand pressurized gases through a patient interface 2 (here, a nasalcannula). The cannula 2 is connected to a gases transportation pathwayor inspiratory conduit 3 that in turn is connected to an integratedgases supply and humidifying device 4 (including a humidificationchamber 5). In the preferred embodiment of the blower-humidifying device4, the gases supply or blower is combined in one housing with thehumidifier and humidification chamber.

In the preferred embodiment, the humidification chamber 5 extends outfrom the housing 10 and is capable in use of being removed and replaced(by a slide on movement) by the patient or other user. Also, the inletport (not shown) to the humidification chamber 5 is internal within thehousing 10. It must be appreciated that the embodiment described abovein relation to the housing and FIGS. 1A-1B merely illustrates one formof the housing of the integrated gases supply and humidifying device. Inother forms the gases supply or blower and humidifier may be in separatehousings.

The inspiratory conduit 3 is connected to an outlet 8 of thehumidification chamber 5 that contains a volume of water 6. Inspiratoryconduit 3 contains heating means or heater wires 7 that heat the wallsof the conduit to reduce condensation of humidified gases within theconduit and the patient interface 2 (nasal cannula). The humidificationchamber 5 is preferably formed from a plastics material and may have ahighly heat conductive base (for example an aluminum base) that is indirect contact with a heater plate (not shown but located at the base ofthe chamber 5, within the blower housing). The gases supply andhumidifying device 4 is provided with control means or an electroniccontroller (illustrated as controller 20) that may comprise amicroprocessor based controller executing computer software commandsstored in associated memory. The controller 20 receives input fromsources such as user input means or dial (not shown) through which auser of the device 4 may, for example, set a predetermined requiredvalue (preset value) of humidity or temperature of the gases supplied topatient 1.

In response to the user set humidity or temperature value input via dial(or buttons) and other possible inputs such as internal sensors thatsense gases flow or temperature, or by parameters calculated in thecontroller 20, the controller 20 determines when (or to what level) toenergize heater plate to heat the water 6 within humidification chamber5. As the volume of water 6 within humidification chamber 5 is heated,water vapor begins to fill the volume of the chamber above the water'ssurface and is passed out of the humidification chamber outlet(illustrated as outlet 8) with the flow of gases (for example air)provided from a blower part of the device that has entered the device 4through an inlet 9 on the back of the gases supply and humidifyingdevice 4.

The gases supply within the device 4 is preferably a variable speed pump22 or fan 23 that draws air or other gases through the blower inlet(illustrated as inlet 9). The speed of variable speed pump 22 or fan 23is preferably controlled by the control means or electronic controller(illustrated as controller 20) described above in response to inputsentered into the device 4 by the user.

As discussed above it would be advantageous to provide oxygen therapywith humidification therapy to patients that suffer from COPD and otherrespiratory disorders. The breathing assistance apparatus of the presentinvention provides this by having a manifold that is attachable toexisting gases supply and humidifying devices, such as, the SleepStyle™600 series CPAP devices of Fisher & Paykel Healthcare Limited. It mustbe noted that any CPAP, auto PAP, bi-level or other flow generatingdevice that provides high gases flow and potentially humidification ofgases may utilize a manifold as described below. The manifold allows theoutput from an oxygen concentrator to be combined with the flow from agases supply and humidifying device and the combined output of oxygenand other breathing gases can then be humidified.

FIG. 2 shows a gases supply and humidifying device 4 with a manifold 11installed. The manifold 11 is shown in further detail in FIGS. 3 to 5.The manifold 11 is preferably a substantially rectangular insert that iscapable of being inserted into the inlet port 9 on the device 4. Themanifold 11 has a recessed edge 12 that fits into a complementary lip onthe inlet port 9 and has an oxygen inlet port 13 to which tubing 14 orthe like can be attached that feeds to an oxygen supply tank or thelike. The oxygen inlet port 13 preferably extends from the side of themanifold 11. The manifold 11 has an extended area 15 that includes atleast one aperture (although two apertures 16, 17 are shown in FIGS. 3to 5). The apertures 16, 17 allow for ambient air to be drawn into thedevice 4 by the action of the pump 22 or fan 23. The ambient air plusoxygen gases are mixed within the device 4 and exit the chamber outlet(illustrated as outlet 8) as humidified air plus oxygen that is thenpassed to the patient via the conduit 3.

A filter 21, for example, a substantially rectangular piece of meshedfilter material or the like, may be placed inside the apertures 16, 17,such that it fits within the inner part of the extended area 15 andfilters all gases entering the blower inlet.

Advantages

This breathing assistance apparatus and manifold of the presentinvention provides a safe method to add oxygen to the input air streamof a gases supply and humidifying device. The full oxygen output fromthe tubing feeding oxygen to the manifold is drawn into the device whenthe device is in use, but if the device is switched off oxygen that isfed into the manifold disperses through the apertures 16, 17 andtherefore remains outside the device 4. Therefore, oxygen does notaccumulate within the device (for example, a gases supply such as ablower) and create a fire risk. Consequently, the manifold lowers thefire hazard risk should a spark occur inside the blower or breathingconduit.

By adding oxygen to the inlet of the flow generation device this oxygencan be fully humidified along with the other gases delivered to thepatient. Prior art systems usually add oxygen after humidification ofgases thus reducing the overall humidification of the gases that reachthe patient.

Furthermore, adding oxygen on the inlet side of the flow source makes itpossible to sense inside the device 4 the fraction of oxygen in thecombined gas flow and display this fraction on a display on the flowsource. Therefore, in a further embodiment the gases supply (blower orintegrated blower and humidifying device 4) includes an internal sensor19 that is capable of sensing the fraction of oxygen through the device4. The internal sensor 19 is preferably connected to the controller 20within the device (as described above) and the controller 20 causes thefraction of oxygen measurement sensed by the internal sensor 19 to bedisplayed on the display 18 (see FIG. 2) that is preferably disposed onthe top of the device 4. As the fraction of oxygen changes and this issensed by the internal sensor 19 preferably this change is updated onthe display in real time.

The breathing assistance apparatus with the manifold of the presentinvention does not require one way valves or sealing caps when an oxygencircuit is not connected to the apparatus and is safe and simple for apatient to operate.

What is claimed is:
 1. A breathing assistance apparatus, comprising: agases supply having an inlet and configured to provide a flow of gases;a humidifier having a humidification chamber and a heater plate at abase of the chamber, the gases supply providing the flow of gases to thehumidifier; a housing in which the gases supply and the humidifier arecombined; and a manifold on or about, and connected to, the inlet, themanifold comprising: an auxiliary inlet port connectable to an auxiliarygases supply, and at least one aperture configured to allow ambientgases to be drawn into the manifold, wherein the manifold enablesauxiliary gases to be added to the ambient gases.
 2. The breathingassistance apparatus of claim 1, wherein the humidification chamber hasan outlet, and the apparatus is configured to allow ambient andauxiliary gases to flow from the inlet, through the humidificationchamber, and out the outlet.
 3. The breathing assistance apparatus ofclaim 1, wherein the humidification chamber is removable, extends outfrom the housing, and can be removed and replaced by a slide onmovement.
 4. The breathing assistance apparatus of claim 1, wherein thegases supply comprises a variable speed pump or fan controlled by acontroller in response to input from a user.
 5. The breathing assistanceapparatus of claim 1, wherein the at least one aperture is configured totake in air when the gases supply is supplying gases, and is configuredto allow auxiliary gases to spill to ambient when the gases supply isnot supplying gases.
 6. The breathing assistance apparatus of claim 1,wherein the auxiliary gases supply comprises an oxygen supply.
 7. Thebreathing assistance apparatus of claim 1, further comprising aninternal sensor capable of sensing a fraction of oxygen flowing throughthe breathing assistance apparatus.
 8. The breathing assistanceapparatus of claim 1, wherein the manifold includes a filter positionedto filter inflowing gases.
 9. The breathing assistance apparatus ofclaim 8, wherein the filter is substantially rectangular and adapted forplacement inside the at least one aperture.
 10. The breathing assistanceapparatus of claim 1, wherein the manifold enables the apparatus tocombine auxiliary gases with ambient gases into combined gases, humidifythe combined gases, and deliver the combined gases to a patient.
 11. Thebreathing assistance apparatus of claim 1, wherein the manifoldcomprises a substantially rectangular insert.
 12. The breathingassistance apparatus of claim 1, wherein the auxiliary gases inlet portextends from a side of the manifold.
 13. The breathing assistanceapparatus of claim 1, wherein the manifold is configured to be retrofitto the breathing assistance apparatus.